# K021217: Arox 53-BP; Arox 60-BP; Arox 45-JBP; Arox 53-JBP

- Pathway: 510(k) (Special)
- Applicant: Biotronik, Inc.
- Decided: May 1, 2002 after 14 days
- Product code: DTB (Permanent Pacemaker Electrode)
- Device class: 3
- Regulation: 21 CFR 870.3680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000763 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010281: Merox Bipolar High Impedance Lead Models: Mex 53/13-BP; 60/15-BP; 45-JBP; 53-JBP, Biotronik, Inc. (2002) Summary page 1.
- K000763: PX 53/15-BP, Model 130 050 and PX 60/15-BP, Model 130 051, Biotronik, GmbH & Co. (2000) Summary page 1.

## Most influential descendants
- K023099: Arox 45-JBP; Arox 53-JBP; Merox 45-JBP; Merox 53-JBP (2002), 0 descendants of its own

## Indications for use
Arox bipolar, passive-fixation, endocardial pacing leads (Arox xx-BP and Arox xx-JBP) are intended to provide permanent pacing and sensing in the atrium and or ventricle when used with a compatible pulse generator.

Source page: https://510kreport.com/device/K021217
Methodology: https://510kreport.com/methodology